New FDA Draft Guidance Addresses Companion Diagnostics

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July 19, 2016

PRECISION MEDICINE
New FDA Draft Guidance Addresses Companion Diagnostics
By Kelly Hardy Briganti, Editorial Director, G2 Intelligence
The U.S. Food and Drug Administration (FDA) released another draft guidance document last week that addresses…
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TESTING STRATEGIES
U.S. Colorectal Cancer Screening Capacity Exists, Although Actual Rates Remain Low
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
The United States has the screening capacity to meet colorectal screening goals, but this capacity has so far not translated into increased screening rates, according to a…
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COMPLIANCE TIPS
Penalties for False Claims Aren't the Only FCA Risk to Avoid
By Kelly Hardy Briganti, Editorial Director, G2 Intelligence
In the last two issues of Lab & Pathology Insider we highlighted new developments concerning the False Claims Act (FCA): the U.S. Supreme Court decision recognizing the…
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EMERGING TESTS
Use of Cologuard Test Will Be Placed in 2017 HEDIS Guidelines
By Ron Shinkman, Editor, Laboratory Industry Report
Exact Sciences' molecular colorectal cancer test will be included in the National Committee for Quality Assurance's (NCQA) updated guidelines for screening for…
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